Acute Graft-versus-host DiseaseaGVHD；BATNCT06593834
A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease After Hematopoietic Stem Cell Transplantation
A study testing bacillus coagulans combined with the best treatment options for preventing aGVHD and BAT in people with Acute Graft-versus-host Disease, run by Yamin Fan.
Trial summary
To evaluate the preventive effect of Bacillus coagulans on acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Graft-versus-host Disease
- What is being tested?
- bacillus coagulans combined with the best treatment options for preventing aGVHD and BAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- No sites listed yet
- Study dates
- 27 Sep 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are fully aware of the study, voluntarily participate and sign informed consent;
- Age: ≥18 years old;
- Patients with hematologic malignancies undergoing allo-HSCT and patients with severe aplastic anemia (SAA) undergoing allo-HSCT were treated with myeloablative conditioning (MAC).
Who cannot join
- Refused to participate in this clinical study;
- Unable to take the drug orally;
- Allergic to Bacillus coagulans;
- People take allo-HSCT with reduced intensity conditioning (RIC) and nonmyeloablative conditioning (NMC);lymphoma or multiple myeloma with auto-HSCT; multiple myeloma patients.
About this study
Official title: A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease (aGVHD) After Hematopoietic Stem Cell Transplantation
To evaluate the preventive effect of Bacillus coagulans on acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation
Read the detailed description
The study is conducted on patients after hematopoietic stem cell transplantation and the intervention is Bacillus coagulans, aiming to investigate the preventive effect of Bacillus coagulans on acute graft-versus-host disease after hematopoietic stem cell transplantation.
- Conditions
- Acute Graft-versus-host Disease
- Being tested
- bacillus coagulans combined with the best treatment options for preventing aGVHD, BAT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bacillus coagulans combined with the best treatment options for preventing aGVHDDrug
BAT means the best treatment options for preventing aGVHD
BATDrug
BAT
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | bacillus coagulans combined with the best treatment options for preventing aGVHD Receives: Drug: bacillus coagulans combined with the best treatment options for preventing aGVHD |
| Control group | Active comparator | The best treatment options for preventing aGVHD Receives: Drug: BAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute graft-versus-host disease
Will acute graft-versus-host disease occur within 100 days after hematopoietic stem cell transplantation and its probability of occurrence
Measured: 100th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Sep 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yamin Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yamin Fan, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593834
- Sponsor's protocol ID
- PRS2400084534
- Acronym
- aGVHD；BAT
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease (aGVHD) After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06593834
- Acronym / sponsor ID
- aGVHD；BAT / PRS2400084534
- Conditions
- Acute Graft-versus-host Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Yamin FanUniversity, hospital or other
- Study start
- 27 Sep 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the preventive effect of Bacillus coagulans on acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation
Detailed description
The study is conducted on patients after hematopoietic stem cell transplantation and the intervention is Bacillus coagulans, aiming to investigate the preventive effect of Bacillus coagulans on acute graft-versus-host disease after hematopoietic stem cell transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: bacillus coagulans combined with the best treatment options for preventing aGVHDbacillus coagulans combined with the best treatment options for preventing aGVHD |
| Control group | Active comparator | Drug: BATThe best treatment options for preventing aGVHD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients are fully aware of the study, voluntarily participate and sign informed consent;
- Age: ≥18 years old;
- Patients with hematologic malignancies undergoing allo-HSCT and patients with severe aplastic anemia (SAA) undergoing allo-HSCT were treated with myeloablative conditioning (MAC).
Key exclusion criteria (4 listed)
- Refused to participate in this clinical study;
- Unable to take the drug orally;
- Allergic to Bacillus coagulans;
- People take allo-HSCT with reduced intensity conditioning (RIC) and nonmyeloablative conditioning (NMC);lymphoma or multiple myeloma with auto-HSCT; multiple myeloma patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bacillus coagulans combined with the best treatment options for preventing aGVHDBAT means the best treatment options for preventing aGVHD | Drug | Experimental group |
| BATBAT | Drug | Control group |
Primary outcome
Rate of acute graft-versus-host disease
Time frame: 100th day
Will acute graft-versus-host disease occur within 100 days after hematopoietic stem cell transplantation and its probability of occurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing bacillus coagulans combined with the best treatment options for preventing aGVHD and BAT in people with Acute Graft-versus-host Disease, run by Yamin Fan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acute graft-versus-host disease (time frame: 100th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.